Integrity

GUDID 00613994602480

Stent INT40012W INTEGRITY 4.00X12W

MEDTRONIC, INC.

Bare-metal coronary artery stent

• Primary Device ID: 00613994602480
• NIH Device Record Key: 44a45816-8ebb-4e15-8d52-89b499c28da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity
• Version Model Number: INT40012W
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994602480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030009

FDA Product Code

• MAF: STENT, CORONARY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2014-09-23

On-Brand Devices [Integrity]

• 00613994798879: Stent INT27526UX INTEGRITY 2.75X26UX
• 00613994798862: Stent INT27522UX INTEGRITY 2.75X22UX
• 00613994798855: Stent INT27518UX INTEGRITY 2.75X18UX
• 00613994798848: Stent INT27514UX INTEGRITY 2.75X14UX
• 00613994798831: Stent INT27512UX INTEGRITY 2.75X12UX
• 00613994798824: Stent INT27508UX INTEGRITY 2.75X08UX
• 00613994798800: Stent INT25026UX INTEGRITY 2.50X26UX
• 00613994798794: Stent INT25022UX INTEGRITY 2.50X22UX
• 00613994798787: Stent INT25018UX INTEGRITY 2.50X18UX
• 00613994798770: Stent INT25014UX INTEGRITY 2.50X14UX
• 00613994798763: Stent INT25012UX INTEGRITY 2.50X12UX
• 00613994798756: Stent INT25008UX INTEGRITY 2.50X08UX
• 00613994798732: Stent INT22526UX INTEGRITY 2.25X26UX
• 00613994798725: Stent INT22522UX INTEGRITY 2.25X22UX
• 00613994798718: Stent INT22518UX INTEGRITY 2.25X18UX
• 00613994798701: Stent INT22514UX INTEGRITY 2.25X14UX
• 00613994798695: Stent INT22512UX INTEGRITY 2.25X12UX
• 00613994798688: Stent INT22508UX INTEGRITY 2.25X08UX
• 00613994798671: Stent INT40030UX INTEGRITY 4.00X30UX
• 00613994798664: Stent INT40026UX INTEGRITY 4.00X26UX
• 00613994798657: Stent INT40022UX INTEGRITY 4.00X22UX
• 00613994798640: Stent INT40018UX INTEGRITY 4.00X18UX
• 00613994798633: Stent INT40015UX INTEGRITY 4.00X15UX
• 00613994798626: Stent INT40012UX INTEGRITY 4.00X12UX
• 00613994798619: Stent INT40009UX INTEGRITY 4.00X09UX
• 00613994798602: Stent INT35030UX INTEGRITY 3.50X30UX
• 00613994798596: Stent INT35026UX INTEGRITY 3.50X26UX
• 00613994798589: Stent INT35022UX INTEGRITY 3.50X22UX
• 00613994798572: Stent INT35018UX INTEGRITY 3.50X18UX
• 00613994798565: Stent INT35015UX INTEGRITY 3.50X15UX
• 00613994798558: Stent INT35012UX INTEGRITY 3.50X12UX
• 00613994798541: Stent INT35009UX INTEGRITY 3.50X09UX
• 00613994798534: Stent INT30030UX INTEGRITY 3.00X30UX
• 00613994798527: Stent INT30026UX INTEGRITY 3.00X26UX
• 00613994798510: Stent INT30022UX INTEGRITY 3.00X22UX
• 00613994798503: Stent INT30018UX INTEGRITY 3.00X18UX
• 00613994798497: Stent INT30015UX INTEGRITY 3.00X15UX
• 00613994798480: Stent INT30012UX INTEGRITY 3.00X12UX
• 00613994798473: Stent INT30009UX INTEGRITY 3.00X09UX
• 00613994602794: Stent INT25026W INTEGRITY 2.50X26W
• 00613994602770: Stent INT27508W INTEGRITY 2.75X08W
• 00613994602763: Stent INT27512W INTEGRITY 2.75X12W
• 00613994602756: Stent INT27514W INTEGRITY 2.75X14W
• 00613994602749: Stent INT27518W INTEGRITY 2.75X18W
• 00613994602732: Stent INT27522W INTEGRITY 2.75X22W
• 00613994602718: Stent INT27526W INTEGRITY 2.75X26W
• 00613994602695: Stent INT30009W INTEGRITY 3.00X09W
• 00613994602688: Stent INT30012W INTEGRITY 3.00X12W
• 00613994602671: Stent INT30015W INTEGRITY 3.00X15W
• 00613994602657: Stent INT22508W INTEGRITY 2.25X08W